FDA issued a safety warning regarding possible navigational accuracy errors linked to frameless stereotaxic navigation systems, although the agency said the overall benefits of using these systems continue to outweigh the risks.
Certain types of stereotaxic navigation systems could produce accuracy errors, according to an FDA safety communication. The agency said some such errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures.
Still, the agency said the overall benefits of using frameless stereotaxic navigation systems continue to outweigh the risks. FDA also said it has not determined that any particular system carries greater risk than others.
Stereotaxic navigation systems include a computer system that uses patient imaging to guide surgeons with the placement of specialized surgical instruments and implants before and during certain procedures. These systems are generally considered either framed or frameless. FDA said navigational accuracy errors may occur when using the frameless stereotaxic navigation systems, which do not require the placement of a frame on the patient's anatomy and tend to be more commonly used. Framed stereotaxic navigation systems require the attachment of a frame to the patient's head using screws or pins, and rely on the fixed location of the frame to calculate a trajectory and distance to a point of interest identified on the patient's image.
Stereotaxic navigation systems may be used during diagnostic biopsies, tumor resections, bone preparation, and implant placement, placement of electrodes, otolaryngologic, or neurosurgical procedures.
FDA said it analyzed data from multiple sources and determined that navigational accuracy errors may occur, and that many factors could contribute to these errors. Some potential causes of the errors include: navigational software or hardware problems; user errors in inputs, system setup, and execution of system and surgical techniques; the use of incompatible accessory instruments with the navigation system; anatomical complexity, including surgical requirements and intraoperative shift, such as brain shift during surgery, local tissue deformation from tissue resection, or spinal movement; registration and tracking errors, including poor registration and movement of the registration fiducials or reference array; and image quality issues, such as insufficient image resolution or incomplete images.
FDA recommended healthcare providers assess navigational accuracy repeatedly throughout a procedure when using a surgical navigation system. The agency also said providers should be aware of any manufacturer's recommended software updates related to the safe performance of the system, and update as needed. Another suggestion from FDA is to inspect the system prior to each use, and not using any devices, components, or accessories that have visible damage, or that have been dropped, or are not performing as expected.
A more complete list of FDA recommendations can be found here.
The agency said it is working with device manufacturers to ensure accurate labeling that includes clear user instructions on how to minimize the occurrence of these issues.
Amanda Pedersen is Qmed's news editor. Contact [email protected].
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